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CirCode Biomed Announces FDA Clearance for IND Application of HM2002, the world's first circular RNA drug being administrated in patients
- CirCode Biomed announced on May 30, 2025, that its circular RNA drug HM2002 received FDA IND clearance for treating ischemic heart disease in the US.
- This milestone follows HM2002’s prior IND approval from China’s NMPA on January 10, 2025, after an investigator-initiated trial started in September 2024 showed promising results.
- HM2002 offers continuous and safe expression of vascular endothelial growth factor , which promotes angiogenesis and improves myocardial perfusion, overcoming current therapies' limited efficacy.
- During the initial investigator-initiated trial conducted at Ruijin Hospital, every participant experienced notable enhancements in cardiac function, and no adverse effects related to the drug were reported, underscoring the treatment’s safety and effectiveness.
- CirCode’s proprietary circular RNA platform, leveraging AI tools, enabled rapid IND approvals, signaling potential advances in circular RNA therapeutics to meet urgent unmet medical needs globally.
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The Berkshire Eagle+78 Reposted by 78 other sources
CirCode Biomed Announces FDA Clearance for IND Application of HM2002, the world's first circular RNA drug being administrated in patients
SHANGHAI, May 30, 2025 /PRNewswire/ -- Shanghai CirCode Biomed Co. Ltd. (CirCode), an innovative biotech company pioneering circular RNA therapies, recently announced that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration…
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